Prevention With the Health and Lifestyle Tool

  • STATUS
    Recruiting
  • End date
    Dec 31, 2024
  • participants needed
    77000
  • sponsor
    Region Skane
Updated on 24 April 2022
Accepts healthy volunteers

Summary

In this study participants will be randomized to use a digital lifestyle tool over three years or to a control group without access to the tool. The investigators will prospectively via clinical registries follow the incidence and development of type 2 diabetes over three years in those using the tool regularly and those in the control group.

Description

Considerable evidence suggest that lifestyle changes can prevent or delay the onset of type 2 diabetes, and self-care behaviors largely determine HbA1c. Modifiable lifestyle factors have been established as key drivers of disease onset, progression, and prognosis, motivating the use of "lifestyle as medicine".

Digital health tools are increasingly incorporated into diabetes care, and have the potential to improve both behavioral and clinical outcomes on a broad basis. However, low levels of uptake, reduced user engagement over time, and low acceptance among patients, raise concerns about their effectiveness.

The objective or this study is to evaluate a new web-based tool, developed at the University Gothenburg, Sweden, that aims to support patient autonomy and motivation to make sustainable lifestyle changes.

The investigators will test the hypothesis that individuals who have access to the tool get lower incidence of type 2 diabetes or in case they already have diabetes develop improved glucose control compared with control individuals. The participants will complete the Findrisc questionnaire to assess the risk for type 2 diabetes to enable analysis of high-risk individuals.

The study is an investigator-initiated single-center study conducted over three years.

The tool is web-based and used via a computer or mobile phone. It is used at each individual's preferred pace but participants are recommended to login at least every other week. Every round the participants choose a themes (out of appr. 80 possible covering e.g. food, exercise, stress, self-reflection aspects), which takes appr. 15-30 minutes to complete. Participants then reflect on the content and how it could be implemented in daily life. When returning for next round participants are asked to reflect on any changes done since last time. There is no interaction between individual participants.

There will be two primary endpoints:

  1. Incidence of type 2 diabetes as measured in non-diabetic participants with increased risk for type 2 diabetes (controls vs. those using the tool regularly)
  2. Change of HbA1c, reflecting long-term blood glucose control, from baseline to end of follow-up in participants who have type 2 diabetes (controls vs. those using the tool regularly).

Details
Condition Type2 Diabetes
Treatment Lifestyle tool
Clinical Study IdentifierNCT05006508
SponsorRegion Skane
Last Modified on24 April 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

informed consent
Age above 35 years

Exclusion Criteria

type 1 diabetes, MODY or secondary diabetes
conditions or treatments that in the judgement of the Investigator could affect the study evaluation
connection with the study team, funders, authorities, universities or other public or private bodies in such a way that specific interests in the study outcomes could be suspected
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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